Medtronic 5867-3M Technical Manual

5867-3M
Lead end cap kit
Technical Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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Medtronic

Description/intended use

The 5867-3M Lead end cap kit consists of three types of lead end caps—one intended to seal off leads with Medtronic unipolar connectors 5 mm (0.2 in) or bipolar connectors 5 mm (0.2 in) bifurcated, one intended to seal off leads with unipolar connectors (IS-11 UNI) or bipolar connectors (IS-1 BI), and one intended to seal off leads with Medtronic bipolar connectors (3.2 mm low profile) or severed lead bodies with an outer diameter of 1.5 to 2.8 mm (4.6 to
8.4 Fr).
All three types of lead end caps are made of silicone rubber.
The Model 5867-3M is intended for single use only.

Package contents

Dispose of all single-use accessories according to local environmental requirements. Each package contains the following items:
2 unipolar 5 mm (0.2 in) lead end caps
1 IS-1 UNI/BI lead end cap
1 bipolar 3.2 mm (0.13 in) low profile lead end cap
Product documentation

Contraindications

To date, there are no known contraindications to the use of the 5867-3M Lead end cap kit.
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IS-1 refers to an International Connector Standard (ISO 5841-3) whereby devices and leads so designated are assured of a basic mechanical fit.
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Warnings and precautions

Note: Medical procedure warnings and precautions
that pertain to the Medtronic implanted system are provided in the manual that is packaged with the device or on the Medtronic Manual Library website (www.Medtronic.com/manuals).
Review the lead documentation – Since the lead end cap is a functional extension of the lead, it is recommended that the lead documentation be reviewed for all appropriate warnings, complications, precautions, and instructions.
Line-powered and battery-powered equipment –
An implanted lead forms a direct current path to the myocardium. During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose to protect against fibrillation that may be caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment.
External defibrillation equipment – Keep external defibrillation equipment nearby for immediate use during the implant procedure and whenever arrhythmias are possible or intentionally induced.
Handling the lead end caps – Lead insulators attract small particles such as lint and dust; therefore, protect the lead end cap(s) from materials shedding these substances.
Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. This device is for single use only and is not intended to be resterilized.
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